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Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Uveitic Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00958906
Recruitment Status : Withdrawn (PI left institution (there are no data results for this study))
First Posted : August 13, 2009
Last Update Posted : June 23, 2011
Information provided by:
Icahn School of Medicine at Mount Sinai

Brief Summary:
The purpose of this study is to determine if intravitreal infliximab is a safe and effective treatment for macular edema secondary to uveitis.

Condition or disease Intervention/treatment Phase
Uveitic Macular Edema Intraocular Inflammation Drug: Infliximab (intravitreal, 2.0mg/0.05ml) Phase 1 Phase 2

Detailed Description:
Participants with uveitic macular edema will be treated with one injection of intravitreal infliximab (2.0mg/0.05ml) and followed for three months. Outcomes that be assessed include best-corrected visual acuity, macular thickness as measured by optical coherence tomography, and electroretinogram responses.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Uveitic Macular Edema
Study Start Date : August 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Infliximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intravitreal infliximab Drug: Infliximab (intravitreal, 2.0mg/0.05ml)
One injection of intravitreal infliximab (2.0mg/0.05ml).
Other Name: Remicade™

Primary Outcome Measures :
  1. Best-corrected visual acuity [ Time Frame: Three months ]

Secondary Outcome Measures :
  1. Macular thickness [ Time Frame: One, two, and three months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Participant must be 18 years of age or older.
  2. Participant must understand and sign the protocol's informed consent document.
  3. Participants must have uveitic macular edema in one eye as defined by all of the following criteria:

    1. Presence of active intermediate uveitis or posterior uveitis.
    2. Macular edema defined as a central macular thickness of ≥ 250 μm on OCT.
    3. Uveitis must be noninfectious as determined by standard investigations used in the diagnostic investigation of uveitis.
  4. Participant must have visual acuity between 20/40 and hand motions in the study eye.
  5. Participant must have a steady fixation in the study eye and media clear enough for good quality imaging.
  6. Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must practice an adequate method of birth control. Males able to father a child must agree to practice birth control. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom and spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy in a partner). If a participant is of childbearing potential, she must be willing to undergo monthly urine pregnancy tests. Both males and females must agree to use adequate birth control for three months after the intravitreal infliximab injection.

Exclusion Criteria:

  1. Participant is in another investigational study and actively receiving study therapy.
  2. Participant is unable to comply with study procedures or follow-up visits.
  3. Participant has uveitic macular edema (as defined above) in both eyes.
  4. Participant has multiple sclerosis or symptoms suggestive of multiple sclerosis.
  5. Participant has evidence of ocular disease other than uveitis in either eye that may confound the outcome of the study (e.g., diabetic retinopathy, age-related macular degeneration, vitreomacular traction, moderate/severe myopia, etc.).
  6. Participant is expected to need ocular surgery in the study eye during the course of the study.
  7. Participant has undergone ocular surgery or an intravitreal/periocular steroid injection in the study eye within the past 3 months.
  8. Participant has had a YAG laser capsulotomy or intravitreal anti-VEGF treatment in the study eye within the past 6 weeks.
  9. Participant has had a pars plana vitrectomy in the study eye.
  10. Participant is on ocular or systemic medications known to be toxic to the lens, retina, or optic nerve.
  11. Participant with a history of ocular herpes simplex virus infection in the study eye.
  12. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).
  13. There are no criteria for inclusion/exclusion for the fellow eye. Only one eye can have macular edema in order for the potential participant to be considered for enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00958906

United States, New York
Department of Ophthalmology, Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Principal Investigator: Farzin Forooghian, MD Icahn School of Medicine at Mount Sinai

Responsible Party: Farzin Forooghian, MD, Assistant Professor, Department of Ophthalmology, Mount Sinai School of Medicine Identifier: NCT00958906     History of Changes
Other Study ID Numbers: GCO # 09-0611
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011

Keywords provided by Icahn School of Medicine at Mount Sinai:
Macular Edema
Intraocular Inflammation

Additional relevant MeSH terms:
Macular Edema
Pathologic Processes
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Uveal Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents